An introduction to ISPE and it's products and services.

2. Founded in 1980
Not-for-profit, non-lobbying
global professional society
25,000 individual Members
from 90 countries
Provides technological
knowledge, education, and
guidance documents for
pharmaceutical industry
Provides forums for exchange
among industry, suppliers,
academia, and regulators
Strong ties with regulatory
authorities worldwide

3. Who Are ISPE’s Members?
ISPE connects pharmaceutical professionals globally from
development through delivery.
ISPE Members represent the full circle of knowledge
required for innovation:
• Industry professionals from companies that manufacture
Pharmaceuticals, Biopharmaceuticals, APIs, Veterinary Medicine,
Generics, Medical Devices and Diagnostics
• Service Providers and Suppliers of Equipment
• Regulatory Authority Leaders
• Academics and Students

4. ISPE Members Work in…

5. ISPE Membership Expertise
• Architect / Engineer / • Project Management
Construction • Quality Assurance/Control
• Clinical / Investigational • Regulatory/Compliance
Materials • Research and Development
• Health / Safety / Environmental • Sales / Marketing /
• Information Technology Business Development
• Logistics/Supply Chain • Technical Services /
Management Product Support
• Maintenance • Training
• Operations / Manufacturing • Validation / Qualification /
• Process Control/Automation Commissioning
• Process Development /
Technology Transfer

6. ISPE Membership is Global

8. How does ISPE Assist its Members?
• Provides access to regulatory and industry
news, information, and resources
• Provides practical application education and
training needed to “get the job done” today,
while equipping you with the skills and
knowledge needed for tomorrow’s challenges
• Provides global and local networking
opportunities through Communities of Practice
and Affiliates and Chapters that foster
collaboration and sharing

9. What Does ISPE Provide to Members?
Critical Information
Networking Opportunities
• ISPE’s Body of Knowledge
• Communities of Practice
• Global Resources through the
• Local Affiliates/Chapters
Society’s Web site at
• Member Directory on-line 24/7
www.ISPE.org
• Global On-line Career
• Pharmaceutical Engineering
Exchange
magazine
• Peer-reviewed Journal of
Professional Growth Pharmaceutical Innovation
• Education and Training • Technical Documents
• Certified Pharmaceutical
Industry Professional
(CPIP™) credential
• On-line learning

10. Communities of Practice (COPs)
Purpose
• Provides forum for community
members to help each other
solve everyday work problems
• Develops and disseminates
best practices, guidelines, and •Connecting members person-to-person
procedures, and creates •Collecting relevant information to share
breakthrough ideas,
knowledge, and practices
• Organizes, manages, and
researches a Body of
Knowledge from which
community members can draw

11. Communities of Practice (COPs)
Current COPs:
• Active Pharmaceutical Ingredients (API)
• Biotechnology
• Commissioning and Qualification
• Containment
• Critical Utilities
• Disposables
Good Automated Manufacturing Practice (GAMP®)
•
• Heating, Ventilation, and Air Conditioning (HVAC)
• Investigational Products
• Packaging
• Process Analytical Technology
• Process/Product Development
• Project Management
• Sterile Products Processing

12. Emerging Economy Members
• Industry professionals from countries the World Bank
classifies as “Emerging Economies”
• Membership Dues: $30/ €30 year
• Full Society benefits with electronic access to publications

13. Student Members
• Special resources and events to help develop your career
• Networking opportunities with top professionals in your field to
fine-tune skills and develop interviewing practices
• More than 40 Student Chapters supported by local ISPE
Affiliates and Chapters at colleges and universities worldwide
• Membership Dues: $15/ €15 per year ($5/ €5 per year for
Emerging Economy countries)

14. International Student Members
Student Members represent the following countries:
Australia Italy
Austria Jordan
Belgium Korea
Canada Malaysia
China Mexico
Czech Republic Poland
Dominican Republic Singapore
Finland Sweden
France Switzerland
Germany Taiwan
India Turkey
Indonesia United Kingdom
Ireland United States

15. How is ISPE Global and Local?
• 90% of ISPE Members belong to an Affiliate or Chapter
• ISPE Members take global issues and determine local
solutions…in the local language
• Affiliate/Chapter events provide a forum for transfer of
industry/regulatory information and technology on a local basis
and access to:
• Educational seminar/training programs
• Industry/regulatory/academia/professional networking
• Facility tours
• Affiliate/Chapter Web sites deal with regional topics in local
language

16. Affiliates/Chapters: Asia Pacific
In Development
Asia Pacific Affiliates
• China
• Australasia
• Indonesia
• Brisbane Chapter
• Melbourne Chapter
• New Zealand Chapter
• Sydney Chapter
• India
• Japan
• Singapore
• Thailand

17. Affiliates/Chapters: Europe
European Affiliates
• Belgium • Spain
• Czech Republic/ • The Netherlands
Slovakia • Turkey
• France • United Kingdom
• Germany/Austria/ • Central Region
Switzerland • Northeast Region
• Ireland • Northwest Region
• Scotland Region
• Italy
• Southern Region
• Nordic
• Poland

18. Affiliates/Chapters: North/South America
South American Affiliates
• Argentina Affiliate • Brazil Affiliate
North American Affiliates
• Canada Affiliate
• Central Canada Chapter
• New England
• United States Affiliate • New Jersey
• Boston Area • Pacific Northwest
• Carolina-South Atlantic • Puerto Rico
• Chesapeake Bay Area • Rocky Mountain
• Delaware Valley • San Diego
• Great Lakes • San Francisco/Bay Area
• Greater Los Angeles Area • South Central
• Midwest

19. ISPE Web site
Your 24/7 Access Point to Knowledge
www.ISPE.org
• On-line Membership Directory • Global Supplier’s
Directory
• Pharmaceutical Engineering
magazine articles: search and • Regulatory News
download
• Reference Documents
• Journal of Pharmaceutical
Innovation articles: search and
• Global Events Calendar
download
• Global Career Exchange
• Technical Glossary of
Pharmaceutical Terms
• Communities of Practice

20. ISPE Professional Certification
The Certified Pharmaceutical Industry Professional (CPIPSM)
• An international competency-based credential
• Eligibility requirements (Bachelor's degree + demonstrated
industry experience)
• Written examination
Value for the professional:
• Enhanced career mobility
• Competitive edge
Value for the employer:
• Global competency standard
• Recruiting tool
Conferred by the ISPE Professional Certification Commission

21. ISPE’s Technical Contribution to the Industry
• Baseline® Pharmaceutical Engineering Guides
• Good Automated Manufacturing Practice (GAMP®)
• ISPE Good Practice Guides
• Providing technical input to regulatory authorities
such as US FDA, EMEA, JMHLW, WHO, and PIC/S
The ISPE logo, tagline, GAMP, and Baseline are registered trademarks of ISPE.

22. Baseline® Pharmaceutical Engineering Guides
Upcoming Guides
Currently Available
• Packaging, Labeling, and
• Active Pharmaceutical
Warehousing Operations
Ingredients, a revision of
(2007)
Bulk Pharmaceutical
• Maintenance (2008)
Chemicals
• Laboratories (2008)
• Oral Solid Dosage Forms
• Sterile Manufacturing
Facilities
• Water and Steam Systems
• Commissioning and
Qualification
• Biopharmaceutical
Manufacturing Facilities

23. ISPE Industry Guidance
• GAMP® 4, Good Automated Manufacturing Practice Guide for
Validation of Automated Systems
• GAMP® 5, Good Automated Manufacturing Practice Guide for
Validation of Automated Systems - 1st quarter 2008
Currently Available GAMP® Good Practice Guides
•
• Calibration Management
• Validation of Process Control Systems
• A Risk-Based Approach to Compliant Electronic Records and
Signatures
• Validation of Laboratory Computerized Systems
• IT Infrastructure Control and Compliance
• Global Information Systems Control and Compliance
• Testing of GxP Systems
• Electronic Data Archiving

24. ISPE Industry Guidance
ISPE Good Practice Guides Currently Available
• Comprehensive Guide to Clinical Materials
• ISPE Good Practice Guide: Technology Transfer
• ISPE Good Practice Guide: Assessing the Particulate Containment
Performance of Pharmaceutical Equipment
• Commissioning and Qualification of Pharmaceutical Water and Steam
Systems
• Biologics for Clinical Materials Professionals
Technical Documents Under Development
• Baseline Guide: Risk Based Manufacture of Active Pharmaceutical Products
(Risk–MaPP)
• Baseline Guide: Biopharmaceutical Process Development and Manufacturing
• ISPE Good Practice Guide: Good Engineering Practice
• ISPE Good Practice Guide: HVAC
• ISPE Good Practice Guide: Pharmaceutical Testing Laboratories
• ISPE Good Practice Guide: Science and Risk-Based Cleaning Process
Development and Validation

25. Facility of the Year Awards (FOYA)
• Competition recognizing state-of-the-art
pharmaceutical manufacturing projects that utilize
new / innovative technologies to improve quality
and reduce costs
• Program provides a platform to showcase new
products and accomplishments, and share of
development of new applications in the areas of:
• Process Innovation
• Project Execution
• Equipment/Innovation
• Facility/Integration
• Energy Efficiency
• Operational Excellence

26. Contact ISPE
ISPE Headquarters
3109 W. Dr. M L King Jr. Blvd., St 250, Tampa, Florida 33607 USA
Tel: +1-813-960-2105 Fax: +1-813-264-2816
E-mail: customerservice@ispe.org
European Office
Avenue de Tervueren, 300, B-1150, Brussels, Belgium
Tel: +32-2-743-44-22 Fax: +32-2-743-15-50
E-mail: ispe@associationhq.com
Asia Pacific Office
73 Bukit Timah Road, #03-01 Rex House, Singapore 229832
Tel: +65 6496 5502 Fax: +65 6336 2263
E-mail: asiapacific@ispe.org
Visit www.ISPE.org for more information